Cerebral Palsy
Conditions
Keywords
pediatric, orthosis, exoskeleton
Brief summary
PlayGait is an investigational dynamic energy storage and return (ESR) lower-limb exoskeleton for young children with cerebral palsy (CP), that stores energy while the child is in the stance phase of walking and returns that energy in terminal stance and early swing phase of walking. PlayGait assists with the passive dynamics of walking through an exotendon (comprised of a spring in series with a cable). The overall objective of this investigational device is to promote correct walking patterns that encourage proper bone alignment, muscle recruitment, and strengthening during walking practice in young children with CP. The study will evaluate children with CP's activity levels in the community with and without PlayGait. The study will consist of three lab visits and two, 7-day periods at home.
Interventions
DEVICEPlayGait
PlayGait is a dynamic energy storing and returning lower-limb exoskeleton.
OTHERBaseline
Baseline condition with no prescribed or intervention lower-limb devices.
Sponsors
National Institute on Disability, Independent Living, and Rehabilitation Research
Orthocare Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
No
Inclusion criteria
* Age 3 - 4 years (at time of informed consent) * Hemiplegic cerebral palsy * If child uses an ankle-foot orthosis (AFO), parent/caregiver is willing to have the child stop wearing their prescribed AFO during data collections (lab sessions and two 7-day periods at home) * Ability to walk at least 10 meters without the use of assistive devices or AFOs * Ability to walk at least 1 minute without the use of assistive devices or AFOs * Stiff knee gait - less than normal knee flexion during swing phase * Hip flexion passive range of motion contracture less than 20 degrees * Gross Motor Function Classification System (GMFCS) Levels I-II * Modified Ashworth Scale (MAS) \<=2 for the gastrocnemius soleus, rectus femoris, and hamstrings * Family has resources to attend all study sessions (transportation, schedule) * Ability to speak and understand in English
Exclusion criteria
* Orthopedic surgery in the last year * Foster children or wards of the state * Use wheelchair or stroller mobility as their primary method of independent mobility * Severe visual impairment such that the visual impairment itself functionally limits mobility * Phenol or Botox injections to the legs in the last 3 months * Uncontrolled seizure disorder, defined as any seizure in the last 3 months that influenced mobility skills and function (seizures which did not affect mobility are acceptable) * Lower limb fracture in the last 3 months * Planned surgery or changes to movement disorder medication during the study period * Inability to understand directions sufficiently to complete the study assessments * Cognitive, behavioral, or any other issues that may not allow for effective study participation * Unwilling to complete the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cadence | 7 days with baseline condition; 7 days with PlayGait condition | Low, medium, and high activity rate |
| Shifts in cadence | 7 days with baseline condition; 7 days with PlayGait condition | Shifts from low to medium cadence and shifts from medium to high cadence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Balance Scale | 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait | Participant completes 14 activity items that measure pediatric balance |
| 1 minute walk test | 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait | The distance walked in one minute |
| Time of PlayGait use | PlayGait condition: 7 days in the community with PlayGait | Amount of time each day that PlayGait is worn |
| Average steps per day | Baseline Condition: 7 days in the community without PlayGait (no lower-limb assistive devices); PlayGait condition: 7 days with PlayGait | Step count per day |
| 10 meter walk test | 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait | The time it takes to walk 10 meters |
Countries
United States
Outcome results
None listed